FDA 510(k) Application Details - K233577

Device Classification Name	More FDA Info for this Device
510(K) Number	K233577
Device Name	Sleepio«
Applicant	Big Health, Inc. 461 Bush St. Suite 200 San Francisco, CA 94108 US Other 510(k) Applications for this Company
Contact	Reuben Lawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2023
Decision Date	08/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review